If a non-exempt human research project is subject to an Federal Wide Assurance (FWA), each individual who will be engaged in the human research needs to be covered under an FWA. The Individual Investigator Agreement may be used by MSU to extend – for one or more research protocols – the applicability of its Federalwide Assurance to cover an individual not affiliated with MSU or otherwise covered by another institution's Federalwide Assurance. The MSU Principal Investigator directs and appropriately supervises all of the collaborative research activities to be performed by the individual investigator outside the assured institution.
The Principal Investigator should inform the MSU IRB of any individuals who need to obtain an Individual Investigator Agreement. In addition, the MSU IRB will obtain clarification from the Principal Investigator as needed to determine whether Individual Investigator Agreements are needed.
The agreement must be read and signed by the Individual Investigator, the Principal Investigator, and the HRPP Director or designee.
A fully executed Individual Investigator Agreement must be in place prior to the engagement of the individual in the human research.